10 mg/ml oral drops, solution 
morphine as opium tincture

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4

In this leaflet: 
1. What Dropizol is and what it is used for 
2. What you need to know before using Dropizol 
3. How to use Dropizol 
4. Possible side effects 
5. How to store Dropizol 
6. Contents of the packaging and other information 

1. What Dropizol is and what it is used for

Dropizol is a medicine that contains morphine.

Dropizol belongs to a group of medicines called propulsion suppressants (gut-suppressing drugs) and is intended for the treatment of adults in symptoms of severe diarrhea when another diarrhea treatment has not had the desired effect.

Dropizol works by inhibiting bowel movements.

2. What you need to know before you use Dropizol

Do not use Dropizol

  • if you are allergic to opium or morphine or any of the other ingredients of this medicine (listed in section 6)
  • if you are addicted to opiates
  • if you have glaucoma (increased pressure in the eye)
  • if you have severe liver or kidney disease
  • if you have alcohol withdrawal ( delirium tremens )
  • if you have a severe head injury
  • if you are at risk of getting paralytic ileus (intestinal upset caused by paralysis of the muscles in the intestine)
  • if you have acute asthma.
  • if you have a chronic lung disease that makes it difficult to breathe (COPD)
  • if you have difficulty breathing due to respiratory depression. Your doctor has informed you if you have this problem. Symptoms may include shortness of breath, cough, or breathing that is slower or weaker than normal.
  • if you have heart failure as a result of lung disease.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Dropizol:

  • if you are older, as older people may react differently to this medicine. Dose one may need to be adjusted.
  • if you have chronic kidney and/or liver disease. Dose one may need to be adjusted.
  • if you are addicted to drugs or alcohol
  • if you have a disease of the gallbladder or gallstones
  • if you have a head injury or increased pressure in the brain
  • if you have impaired consciousness
  • if you are taking antidepressants (moclobemide or other MAO inhibitors ) or have stopped taking these medicines in the last 2 weeks.
  • if you have impaired adrenal cortex function
  • if you have impaired thyroid function, as does one may need to be adjusted.
  • if you have low blood pressure due to decreased blood volume
  • if you have pancreatitis
  • if you have prostate hyperplasia (prostate enlargement) and/or a disease that may make it difficult for you to empty your bladder
  • if you have an infection or inflammation in the intestines, as inhibition of bowel movements can increase the risk of toxic substances being absorbed into the body and that the large intestine expands or that there are holes in the intestines.
  • if you have epilepsy
  • if you are taking other medicines for diarrhea
  • if you experience seizures
  • if you have bleeding in the stomach and/or intestines
  • if you are taking medicines for high blood pressure.

If you have difficulty urinating, contact a doctor or other healthcare professional.

Dropizol is not recommended before surgery or within 24 hours after surgery due to the risk of intestinal upset (paralytic ileus ). The symptoms of this are nausea and vomiting.

There is a risk of dependence and tolerance development when using the drug.

Children and young people

Dropizol should not be used by children and adolescents under 18 years of age.

Other medicines and Dropizol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must tell your doctor or pharmacist if you are taking:

  • medicines and other substances that aggravate impaired consciousness and difficulty breathing (as seen with Dropizol) such as- alcohol- sleeping pills (eg zolpidem) and anesthetics (eg barbiturates )- medicines used to treat depression ( tricyclic antidepressants ) or Parkinson’s disease ( MAO inhibitors, eg safinamide)- antipsychotics that have a sedative (sedative) effect (eg phenothiazines)- medicines to treat epilepsy (gabapentin)- medicines that relieve nausea and vomiting (eg bromopride, meclizine, metoclopramide)- drugs that relieve allergy ( antihistamine s, such as carbinoxamine, doxylamine) – other pain medicines containing opioid s (eg, alfentanil, butorphanol, fentanyl, hydrocodone, hydromorphone, levorphanol, pethidine (meperidine), methadone, oxycodone, oxymorphone, remifentanil, sufentanil, tapentadol, tramadol).
  • drugs that have a similar mechanism of action to morphine and therefore may increase withdrawal symptoms and reduce the therapeutic effect (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine).
  • drugs for the treatment of alcohol dependence ( disulfiram ) or medicines for the treatment of certain infections (metronidazole), as this can cause unpleasant side effects such as redness, rapid breathing, and rapid heart rate
  • drug for the treatment of tuberculosis (rifampicin), as it reduces the effect of morphine.
  • amphetamine and amphetamine analogs, as they may reduce the sedative effect of opioids.
  • loxapine and pericyazine, as they can increase the sedative effects of opioids s
  • flibanserin, and opioid you, since simultaneous use may involve an increased risk of inhibition of the central nervous system ( CNS -depression).
  • desmopressin or sertraline as Dropizol ( opioid s) may increase plasma concentrations of these drugs
  • zidovudine (a medicament to treat or prevent HIV – infection s)
  • drugs for the treatment of depression ( fluoxetine ), as it may shorten the duration of action of morphine.

Concomitant use of Dropizol and sedatives such as benzodiazepines or similar drugs increase the risk of drowsiness, difficulty breathing ( respiratory depression ), coma, and may be life-threatening. Concomitant use should therefore only be considered when other treatment options are not possible. However, if your doctor prescribes Dropizol with sedatives, the dose and duration of treatment with concomitant treatment should be limited by your doctor. Inform your doctor about all sedatives you are taking and follow your doctor’s dose recommendations carefully. It can be good to inform friends and relatives to be aware of the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

Concomitant use of morphine may potentiate the effects of antihypertensive or other antihypertensive drugs.

Dropizol with food, drink, and alcohol

Dropizol can be taken with food and drink. Dropizol contains alcohol, so extra caution should be exercised when consuming alcohol. See “Dropizol contains ethanol” below.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Dropizol during pregnancy unless your doctor tells you to. Dropizol should not be taken near the date of birth due to the risk of withdrawal symptoms in the newborn.

Breast-feeding

Dropizol should only be used during breast-feeding after consulting your doctor, as morphine passes into breast milk. Infants should be closely monitored for signs of sedation or difficulty breathing.

Fertility

It is not known whether morphine can harm the ability to have children. Men and women of childbearing potential should use effective contraception when using Dropizol.

Driving and using machines

Dropizol contains morphine and ethanol and may cause drowsiness and significantly affect your ability to drive or use machines.

Do not drive after taking your medicines until you know how they affect you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dropizol contains ethanol

This medicine contains 33% by volume of ethanol (alcohol), ie up to 260 mg per dose, equivalent to 6.6 ml of beer or 2.8 ml of wine per dose. Harmful to people suffering from alcoholism. Attention should be paid to pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to use Dropizol

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose in adults is:

Adults: 5-10 drops 2-3 times daily.

One dose should not exceed 1 ml and the total daily dose should not exceed 6 ml.

Elderly: Treatment should be initiated at a low dose.

Hepatic impairment: Dropizol should not be used or the dose should be reduced. See section 2 “Do not take Dropizol” and section 2 “Warnings and precautions”.

Renal impairment: Dropizol should not be used or dose one should be reduced. See section 2 “Do not take Dropizol” and section 2 “Warnings and precautions”.

1 ml Dropizol is equivalent to about 20 drops.

Method of administration:

To be swallowed.

Dropizol can be used undiluted or mixed in a glass of water. After mixing Dropizol with water, it should be taken immediately. If Dropizol is used undiluted, the correct dose can be taken with a spoon.

Use for children and adolescents

Dropizol should not be used by children and adolescents under 18 years of age.

If you use more Dropizol than you should 

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have taken too much Dropizol, you may have small pupils, slow heart rate, low blood pressure, pulmonary edema, difficulty breathing, and decreased consciousness which may lead to coma.

If you forget to use Dropizol

You should take the missed dose as soon as you remember unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Dropizol

Keep taking this medicine for as long as your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Common (may affect more than 1 user in 10):

Difficulty urinating

Uncommon (may affect more than 1 user in 100)

Shortness of breath, fatigue, anxiety, blue lips, fingers and toes, headache, confusion, seizures and swelling of the legs and feet ( respiratory depression ) Cardiac arrhythmia (fast or slow heart rate)

Other side effects are

Very common (may affect more than 1 user in 10):

Drowsiness and constipation, dry mouth.

Common (may affect more than 1 user in 10):

Dizziness, headache, pupil contraction, nausea and vomiting, loss of appetite, indigestion or abdominal discomfort, changes in taste or smell, hives, sweating, bronchospasm ( bronchospasm ), decreased cough, weakness ( asthenia ).

Uncommon (may affect more than 1 in 100 people): Reddening of the face, itching, cramps in the lower urinary tract, abnormal liver values.

Rare (may affect more than 1 of 1 000): Elevated pancreatic enzymes (detected in the blood samples) and pancreatitis, pain due to kidney stones ( renal colic ) or gallstones(biliary colic), withdrawal symptoms, orthostatic hypotension (a form of low blood pressure that occurs when you get up from a sitting or lying position).

Very rare (may affect more than 1 in 10,000 people): Shortness of breath, muscle cramps, seizures, burning and stinging pain, increased sensitivity to pain, blurred vision, double vision, involuntary eye movements, a condition in which the intestine does not function properly ( ileus, intestinal upset), abdominal pain, skin rash, swelling of the hands, ankles or feet, malaise, chills, syndrome with inadequate secretion of antidiuretic hormone (SIADH) (symptoms: nausea, malaise, headache, fatigue and in severe cases further development to seizures and coma ), missed menstruation.

No known frequency (frequency can not be calculated from the available data): Adrenal insufficiency (fatigue, weight loss, fainting, low blood sugar, nausea, diarrhea, vomiting, and abdominal pain), elation (a strong feeling of well-being, joy, and excitement), uncontrolled muscle spasms, depression (sad, without energy), restlessness, decreased sex drive or potency, hallucinations, dizziness, and fever.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Dropizol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and bottle after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

The opened bottle is durable for 4 weeks.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is: morphine as an opium tincture

  • 1 ml oral solution contains 1 ml tincture of Papaver somniferum L., succus siccus (raw opium) equivalent to 10 mg morphine.
    1 drop contains 50 mg opium tincture corresponding to 0.5 mg (10 mg / ml) anhydrous morphine.
    1 ml contains 20 drops.

– Extractant: ethanol 33% (v / v)

– Excipients

  • Ethanol 96% (v / v)
  • Purified water

What the medicine looks like and the contents of the pack

Dropizol is a dark, reddish-brown liquid. It is provided in a brown glass bottle with a pipette and a child-resistant closure.

Pack sizes: 1 x 10 ml, 2 x 10 ml, 3 x 10 ml, 4 x 10 ml, 5 x 10 ml and 10 x 10 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pharmanovia A / S

Copenhagen Towers Ørestads Boulevard 108

DK-2300 Copenhagen S

Denmark

email: info@pharmanovia.com

Manufacturer

Lomapharm GmbH

Langes Feld 5

D-31860 Emmenthal

Germany

Further information about this medicine is available on the Medical Products Agency’s website www.lakemedelsverket.se.

This medicinal product is authorized under the European Economic Area under the names:

Denmark Dropizol
Iceland Dropizol
Finland Dropizol
Norway Dropizol
UK Dropizol
Austria Dropizol
Belgium Dropizole
Czech Republic Dropizol
Germany Dropizol
Spain Dropizol
France Dropizol
Hungary Dropizol
Ireland Dropizol
Italy Dropizole
Luxembourg Dropizol
Netherlands Dropizol
Portugal Dropizol
Romania Dropizol
Slovakia Dropizol

Muhammad Nadeem

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